Effectiveness of Renal Denervation in Resistant Hypertension: A Meta-Analysis of 11 Controlled Studies
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REVIEW ARTICLE
Effectiveness of Renal Denervation in Resistant Hypertension: A Meta-Analysis of 11 Controlled Studies 1 1 1 • Michele Covella • Elena Berra • Chiara Fulcheri • Marco Pappaccogli1 1 • 1 • 1 • 1 • Silvia Di Monaco Elisa Perlo Jacopo Burrello Silvia Monticone Denis Rossato2 Franco Rabbia1 • Franco Veglio1
•
Received: 17 April 2018 / Accepted: 27 April 2018 Ó Springer International Publishing AG, part of Springer Nature 2018
Abstract Introduction Early uncontrolled studies reported large blood pressure reductions in subjects with resistant hypertension treated with renal denervation, however these results were not confirmed in several of the latest publications. Aim The aim of the current study was to evaluate the effectiveness of RDN in controlled studies comparing RDN to either a sham procedure or to medical therapy. Method Only controlled studies were included in the analysis. Both the unadjusted and control-adjusted BP changes were calculated. Results We identified 11 publications of which only 3 were double-blinded RCTs with a sham control, while 8 were open label studies where the control group was treated with medical therapy. Only 2 studies assessed adherence to medical therapy with robust methodologies. Office BP reduction (- 18/8 mmHg) significantly
overestimated ABPM change (- 9/- 5 mmHg), with high heterogeneity between the included studies. When the treatment effect was adjusted for the BP change in the control group, BP changes became non significant (ABPM: - 1.8 for systolic BP [95% CI - 4.5 to 0.9] and - 0.6 for diastolic BP [95% CI - 2.3 to 1.2]). These results were confirmed when only the sham-controlled studies were analysed. Conclusions In spite of promising results in early reports, renal denervation fails to show superiority to a sham procedure or to medical therapy in recently published controlled studies. Lack of a sham control in most publications and heterogeneity in assessment of treatment adherence may account for part the variability reported in the studies.
Marco Pappaccogli, Michele Covella, Elena Berra, Chiara Fulcheri, Silvia Di Monaco, Elisa Perlo, Jacopo Burrello, Silvia Monticone, Denis Rossato, Franco Rabbia and Franco Veglio contributed equally to the study.
1 Introduction
Previous presentations: the main results of this meta-analysis were presented as an oral abstract at the 27th European Meeting on Hypertension and Cardiovascular Protection, 2017 Milan. & Marco Pappaccogli [email protected] 1
Division of Internal Medicine and Hypertension, Department of Medical Sciences, University of Turin, Via Genova 3, 10126 Turin, Italy
2
Radiology Unit, Citta` della Salute e della Scienza, Department of Medical Sciences, University of Turin, Turin, Italy
Keywords Drug adherence Invasive therapy Hypertension Meta-analysis Resistant hypertension Renal denervation
Resistant hypertension (RH) is defined as an office blood pressure (BP) C 140/90 mmHg despite the use of three or more antihypertensive drugs, including a diuretic. Studies demonstrate
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